# K222680: DeltaScan Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Prolira B.V.
- Decided: Feb 2, 2023 after 149 days
- Product code: NCG (Neuropsychiatric Interpretative Electroencephalograph Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.1440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN110019 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN110019: Neba System, Lexicor Medical Technology, LLC (2013) Summary page 4.

## Most influential descendants
- K251936: Ceribell Delirium Monitor System (2025), 0 descendants of its own

## Indications for use
The DeltaScan Monitor provides the binary DeltaScan Output based on a technical index of polymorphic delta (PMD) waveshape detections made in the EEG from the bipolar Fp2 and Pz channel on adult patients (over 60 years of age) to aid in the diagnosis of acute encephalopathy. DeltaScan should only be used by a healthcare provider as a component of a complete clinical evaluation or as support for the clinician's decision to pursue further testing. The device is NOT to be used as a stand-alone method in the evaluation or diagnosis of acute encephalopathy. The intended patient is a hospitalized, awake adult, who is at risk of acute encephalopathy and delirium as decided by the responsible licensed healthcare physician or a medical professional working under the responsibility of a licensed healthcare physician. The use environment is in hospitals: • non-sterile environments; • ICUs, wards, and other patient evaluation locations; The DeltaScan Monitor is intended to be used in combination with the DeltaScan Patch (K222671) through a proprietary connector design. Please refer to the Instructions for Use and the Instructions for Use on the Primary packaging of the DeltaScan Patch for more information.

Source page: https://510kreport.com/device/K222680
Methodology: https://510kreport.com/methodology